Kristin Zielinski Duggan

With a background in biology and economics, Kristin Zielinski Duggan provides strategic advice to companies on scientific and U.S. Food and Drug Administration (FDA) regulatory challenges, while always keeping business needs in mind. For the past 17+ years, she has been counseling cutting-edge companies regarding the development and regulation of medical devices, pharmaceuticals, and combination products.

Kristin has a wealth of experience with the entire FDA regulatory process and agency interactions, from devising regulatory strategy for innovative products to pre-submission meetings; to assisting with preclinical and clinical programs and IDEs; to preparing regulatory submissions (510(k)s), de novo petitions and premarket approvals (PMAs); to appeals of agency decisions. Having prepared companies for dozens of advisory panel meetings over the years — including panel meetings to review 510(k) notices and PMAs, general issues panels, and classification panels — Kristin is a top thought leader in this area. She has been involved with all of the meetings of the Medical Devices Dispute Resolution Panel (MDDRP) to date.

Kristin also assists companies with compliance challenges, including 483 and Warning Letter responses, adverse events reporting, recalls, Department of Justice (DOJ) investigations, and product liability litigation, as well as with due diligence for investments and acquisitions.

Kristin previously served as Vice President for Strategic Consulting at a Washington, D.C.-based scientific consulting firm. Throughout her career, she has published and presented on various FDA regulatory issues. She is also an adjunct professor teaching an experiential seminar on FDA Regulation of Medical Products (Medical Devices, Drugs, and Biologics), which is part of the Executive Master of Science in Health Systems Administration (EMHSA) program at Georgetown University's School of Nursing and Health Studies.

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